Moderna Faces Patent Lawsuit from BioNTech Over COVID-19 Vaccine
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 hours ago
0mins
Should l Buy MRNA?
Source: seekingalpha
- Patent Infringement Lawsuit: BioNTech has filed a lawsuit against Moderna in Delaware federal court, alleging that its COVID-19 vaccine mNEXSPIKE infringes on BioNTech's patent related to its rival product Comirnaty, highlighting escalating legal disputes among vaccine manufacturers.
- Patent Details Revealed: The lawsuit cites Patent No. 12,133,899, which covers a streamlined messenger RNA vaccine design that BioNTech claims to have discovered while developing Comirnaty with Pfizer, underscoring its innovation in vaccine development.
- Revenue Impact Estimate: According to the lawsuit, Moderna's mNEXSPIKE vaccine is expected to account for 55% of its vaccine revenue during the 2025/26 respiratory virus season, indicating that this lawsuit could pose a significant threat to Moderna's future revenue.
- Legal Response Statement: A Moderna spokesperson stated that the company is aware of the lawsuit and will actively defend against these claims, demonstrating its legal defense strategy, although BioNTech has not yet responded to the matter.
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Analyst Views on MRNA
Wall Street analysts forecast MRNA stock price to fall
20 Analyst Rating
1 Buy
16 Hold
3 Sell
Hold
Current: 46.600
Low
17.00
Averages
32.47
High
63.00
Current: 46.600
Low
17.00
Averages
32.47
High
63.00
About MRNA
Moderna, Inc. is a biotechnology company. The Company is advancing a new class of medicines made of messenger ribonucleic acid (mRNA). It is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a spectrum of diseases. The Company’s diverse development pipeline consists of 44 therapeutic and vaccine programs, 11 of which are in late-stage development. Its commercial products include Spikevax (its COVID vaccine) and mRESVIA (its respiratory syncytial virus (RSV) vaccine). Additionally, it has achieved four positive Phase III data readouts for its COVID vaccine (mRNA-1283), its RSV vaccine for high-risk adults aged 18 to 59 (mRNA-1345), its seasonal flu+COVID vaccine (mRNA-1083), and its seasonal flu vaccine (mRNA-1010).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
MODERNA STOCK RISES 6.6% FOLLOWING FDA'S START OF REVIEW FOR COMPANY'S INFLUENZA VACCINE
Moderna's Share Performance: Moderna's shares have increased by 6.6% following a review by the FDA.
FDA Review Focus: The FDA's review pertains to the influenza vaccine developed by Moderna.
See More
Moderna Shares Surge Following FDA's Start of Flu Vaccine Review
- FDA Review Announcement: The U.S. Food and Drug Administration (FDA) will begin reviewing Moderna's investigational seasonal flu vaccine.
- Company Statement: Moderna announced the initiation of the review on Wednesday.
See More
Moderna's mRNA-1010 Marketing Application Accepted by FDA
- FDA Acceptance: The U.S. FDA has accepted Moderna's marketing application for mRNA-1010, marking a significant advancement in the company's vaccine development, with a target action date set for August 5, 2026, thereby laying the groundwork for future market expansion.
- Revised Application Pathway: During a Type A meeting with the FDA, Moderna proposed an amended biologics license application (BLA) that includes an age-dependent regulatory pathway and a post-marketing requirement for additional trials in older adults, demonstrating the company's commitment to regulatory compliance.
- Market Expectations: Moderna plans to launch mRNA-1010 for adults aged 50 and older in the 2026/2027 flu season, a strategy that not only addresses the demand for flu vaccines among the elderly but also has the potential to enhance the company's market share and brand influence.
- Stock Price Recovery: Following the FDA's acceptance of the application, Moderna's shares gained in premarket trading, reflecting investor optimism about the company's future growth potential, especially after facing pressure from last week's FDA refusal-to-file letter.
See More
Moderna's COVID-19 Vaccine mNEXSPIKE Receives EU Marketing Authorization
- EU Marketing Authorization: Moderna's COVID-19 vaccine mNEXSPIKE has received marketing authorization from the European Commission for individuals aged 12 and older, marking the company's third product approved in the EU, thereby enhancing its competitive position in the global vaccine market.
- Clinical Trial Results: In a randomized, controlled Phase 3 trial involving approximately 11,400 participants, mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy compared to Spikevax, with a 13.5% increase in adults aged 65 and older, providing strong support for its market launch.
- Safety Profile: The safety profile of mNEXSPIKE is comparable to Spikevax, with fewer local reactions and similar systemic reactions, and the most commonly reported adverse effects include injection site pain, fatigue, headache, and myalgia, indicating good tolerability.
- Market Outlook: Moderna has already secured regulatory approval for mNEXSPIKE in the U.S., Canada, and Australia, and is pursuing additional market authorizations worldwide, which is expected to drive future revenue growth for the company.
See More
Moderna Faces Patent Lawsuit from BioNTech Over COVID-19 Vaccine
- Patent Infringement Lawsuit: BioNTech has filed a lawsuit against Moderna in Delaware federal court, alleging that its COVID-19 vaccine mNEXSPIKE infringes on BioNTech's patent related to its rival product Comirnaty, highlighting escalating legal disputes among vaccine manufacturers.
- Patent Details Revealed: The lawsuit cites Patent No. 12,133,899, which covers a streamlined messenger RNA vaccine design that BioNTech claims to have discovered while developing Comirnaty with Pfizer, underscoring its innovation in vaccine development.
- Revenue Impact Estimate: According to the lawsuit, Moderna's mNEXSPIKE vaccine is expected to account for 55% of its vaccine revenue during the 2025/26 respiratory virus season, indicating that this lawsuit could pose a significant threat to Moderna's future revenue.
- Legal Response Statement: A Moderna spokesperson stated that the company is aware of the lawsuit and will actively defend against these claims, demonstrating its legal defense strategy, although BioNTech has not yet responded to the matter.
See More
Bridgewater Associates Acquires Dell and UnitedHealth, Divests AT&T Shares
- Portfolio Changes: Bridgewater Associates made significant adjustments to its investment portfolio in the fourth quarter.
- Exiting Investments: The hedge fund exited its position in a major wireless carrier as part of its strategy.
- Healthcare Holdings: Bridgewater also readjusted its investments in the healthcare sector.
- Market Position: As the largest hedge fund globally by assets under management, these changes reflect its ongoing strategy to optimize performance.
See More
MODERNA STOCK RISES 6.6% FOLLOWING FDA'S START OF REVIEW FOR COMPANY'S INFLUENZA VACCINE
Moderna's Share Performance: Moderna's shares have increased by 6.6% following a review by the FDA.
FDA Review Focus: The FDA's review pertains to the influenza vaccine developed by Moderna.
See More
Moderna Shares Surge Following FDA's Start of Flu Vaccine Review
- FDA Review Announcement: The U.S. Food and Drug Administration (FDA) will begin reviewing Moderna's investigational seasonal flu vaccine.
- Company Statement: Moderna announced the initiation of the review on Wednesday.
See More
Moderna's mRNA-1010 Marketing Application Accepted by FDA
- FDA Acceptance: The U.S. FDA has accepted Moderna's marketing application for mRNA-1010, marking a significant advancement in the company's vaccine development, with a target action date set for August 5, 2026, thereby laying the groundwork for future market expansion.
- Revised Application Pathway: During a Type A meeting with the FDA, Moderna proposed an amended biologics license application (BLA) that includes an age-dependent regulatory pathway and a post-marketing requirement for additional trials in older adults, demonstrating the company's commitment to regulatory compliance.
- Market Expectations: Moderna plans to launch mRNA-1010 for adults aged 50 and older in the 2026/2027 flu season, a strategy that not only addresses the demand for flu vaccines among the elderly but also has the potential to enhance the company's market share and brand influence.
- Stock Price Recovery: Following the FDA's acceptance of the application, Moderna's shares gained in premarket trading, reflecting investor optimism about the company's future growth potential, especially after facing pressure from last week's FDA refusal-to-file letter.
See More
Moderna's COVID-19 Vaccine mNEXSPIKE Receives EU Marketing Authorization
- EU Marketing Authorization: Moderna's COVID-19 vaccine mNEXSPIKE has received marketing authorization from the European Commission for individuals aged 12 and older, marking the company's third product approved in the EU, thereby enhancing its competitive position in the global vaccine market.
- Clinical Trial Results: In a randomized, controlled Phase 3 trial involving approximately 11,400 participants, mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy compared to Spikevax, with a 13.5% increase in adults aged 65 and older, providing strong support for its market launch.
- Safety Profile: The safety profile of mNEXSPIKE is comparable to Spikevax, with fewer local reactions and similar systemic reactions, and the most commonly reported adverse effects include injection site pain, fatigue, headache, and myalgia, indicating good tolerability.
- Market Outlook: Moderna has already secured regulatory approval for mNEXSPIKE in the U.S., Canada, and Australia, and is pursuing additional market authorizations worldwide, which is expected to drive future revenue growth for the company.
See More
Moderna Faces Patent Lawsuit from BioNTech Over COVID-19 Vaccine
- Patent Infringement Lawsuit: BioNTech has filed a lawsuit against Moderna in Delaware federal court, alleging that its COVID-19 vaccine mNEXSPIKE infringes on BioNTech's patent related to its rival product Comirnaty, highlighting escalating legal disputes among vaccine manufacturers.
- Patent Details Revealed: The lawsuit cites Patent No. 12,133,899, which covers a streamlined messenger RNA vaccine design that BioNTech claims to have discovered while developing Comirnaty with Pfizer, underscoring its innovation in vaccine development.
- Revenue Impact Estimate: According to the lawsuit, Moderna's mNEXSPIKE vaccine is expected to account for 55% of its vaccine revenue during the 2025/26 respiratory virus season, indicating that this lawsuit could pose a significant threat to Moderna's future revenue.
- Legal Response Statement: A Moderna spokesperson stated that the company is aware of the lawsuit and will actively defend against these claims, demonstrating its legal defense strategy, although BioNTech has not yet responded to the matter.
See More
Bridgewater Associates Acquires Dell and UnitedHealth, Divests AT&T Shares
- Portfolio Changes: Bridgewater Associates made significant adjustments to its investment portfolio in the fourth quarter.
- Exiting Investments: The hedge fund exited its position in a major wireless carrier as part of its strategy.
- Healthcare Holdings: Bridgewater also readjusted its investments in the healthcare sector.
- Market Position: As the largest hedge fund globally by assets under management, these changes reflect its ongoing strategy to optimize performance.
See More
